The amendment concerns a new batch of BriaCell’s whole cell cancer vaccine candidate BriaVax, and the firm’s cell line testing platform for BriaVax – BriaTest (SV-BR-1).
BriaVax is based on a breast cancer cell line engineered to express GM-CSF, an immunostimulatory cytokine , currently in Phase I/IIa development for patients with stage IV breast cancer.
BriaTest is used to evaluate patient suitability for BriaVax, based on sensitivity to the cell line used in the vaccine.
If the US FDA accepts the amendment, BriaCell is planning to start Phase I/IIa trials for BriaVax before the end of March.
William Williams, CEO of Briacell, told Biopharma-Reporter “the CMC amendment is needed as this is a new batch of BriaVax.”
“This is a routine regulatory filing needed for all new batches of cell based therapies.”
The firm has operations in both US and Canada, and has partnered up with the Texas-based contract research organisation Cancer Insight LLC for the trial itself, with manufacturing at the University of California Davis GMP facilities.
“The FDA green light will clear the path for the clinical development of BriaVax [and] BriaDx,” adding “We look forward to working with the FDA in this key milestone," he added.
Williams told us UC Davis' facility in Sacramento is where BriaVax is grown in simple tissue media, before irradiation of the batches and preparation for shipping.
The site offers six GMP manufacturing rooms equipped for production of stem cell therapies, and BriaCell also has operations nearby in Berkeley.
Williams added that BriaCell “may use” World Courier, a cold chain logistics provider, to transport the vaccines to the clinical trial at St Joseph’s Health Center in Santa Rosa, California.
“Process development is ongoing to allow BriaVax to then be frozen following irradiation and shipped to clinical sites on demand,” he explained.